The DarrowEverett Health Care & Life Sciences Practice advises clients across the heavily regulated and consistently evolving health care and life sciences industry. Service providers including hospitals; facilities; manufacturers; suppliers; lenders; investors; academia; and healthcare technology, biotechnology, food and dietary supplement, insurance, medical device, and pharmaceutical companies turn to us for assistance with the myriad of legal and regulatory issues and challenges that they face day to day in their businesses.
The DE team has extensive experience in healthcare mergers, acquisitions, joint ventures; strategic positioning, restructuring, capital access, private equity investments, divestitures, and bankruptcies. We aid with licensing, tax issues, government investigations, employment matters, governance, regulatory compliance, and Medicare/Medicaid reimbursement disputes and have litigated complex disputes involving commercial transactions and allegations of fraud, anti-kickback, and false claims act violations.
Our clients that manufacture or market products regulated by the US Food and Drug Administration (FDA) must also deal with the constantly changing procedural, regulatory, and legislative matters surrounding compliance, enforcement and product development, approvals, launch, sales, and marketing, reporting obligations, disclosures, and recalls.
The DE Health Care Practice Group regularly advises clients on:
- Mergers, Acquisitions, & Sales
- Financing, Restructuring, & Leasing
- Medicare & Medicaid Reimbursement Disputes
- Intellectual Property Issues
- Licensure & Credentialing
- Heath Insurance Portability & Accountability Act
- Anti-kickback Laws
- Corporate Integrity Agreements
- Corporate, Regulatory, & Security Compliance
- Employment, Contracting, & Negotiation
- Stark Law
- False Claims Act
- Qui Tam Actions
- FDA Registration
- Health Information Technology
- Litigation, Arbitration, & Administrative Hearings
- Government Enforcement Actions
- Federal & State Regulatory Compliance
- Products Liability
- Strategic Positioning
- Senior & Elder Care Services
- Clinical Investigations
- Dispute Resolution
- Labeling, Advertising, & Promotion
- Product Recalls
Practice Leader
Kevin P. Gildea - Partner
Overview
Kevin P. Gildea is a Partner and the Practice Leader for DarrowEverett’s Healthcare and Life Sciences, a Practice Leader in its Regulatory & Compliance Practice Group, a Practice Leader in the Data Privacy & Cybersecurity Group, and the co-head of the Corporate Department. He has a practice concentrated in the areas of corporate, banking, healthcare and life sciences, renewable energy, non-profit, and financial services regulation, compliance, litigation and enforcement defense, and transaction and merger-acquisition related structuring,...
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Contact our Healthcare and Life Sciences Group.
Please contact us to let us know how DarrowEverett can serve you.
DE Insights
Our team wants you to stay informed about legal and regulatory developments that impact your business.
Diversity Driven Derivative Suits: Culture Wars Come to the Boardroom
Traditionally deployed to protect a corporation from its board’s imprudent investment or financial decision-making, in recent years shareholders have taken to bringing derivative actions on a corporation’s behalf for its board’s alleged failure to pay more than lip service to the diversity, equity and inclusion (“DEI”) commitments the company publicly proclaims. Spurred in 2020 in…
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Court Rulings Demonstrate That Privilege Is Not Always a Right
Earlier this year, following oral argument and 16 amicus submissions, the Supreme Court dismissed as improvidently granted (“DIG”)[1] a writ of certiorari on the issue of whether communications involving both legal and non-legal advice are protected by the attorney-client privilege.[2] This red-hot issue was granted review following the decision styled In Re Grand Jury, in…
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Danger, Does Not Compute: SEC Takes Aim at Predictive Data Analytics Per Proposed Rules
On July 26, 2023, the Securities and Exchange Commission (“SEC”), in a 3-2 vote, issued a release (the “Release”) containing proposed rules to address conflicts of interest associated with broker dealers’ and investment advisers’ use of predictive data analytics (“PDA”) technologies, and PDA-like technologies, when interacting with investors.[1] The SEC’s proposed rules amend Rules 151-2,…
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Commercial Real Estate
Commercial Real Estate
DarrowEverett’s Commercial Real Estate team is known for its ability to handle complex real estate transactions, ranging from large-scale residential properties and projects to more specialized types of properties and projects…
Banking & Finance
Banking & Finance
DarrowEverett’s Banking and Finance Practice globally represents a wide variety of clients in cutting-edge financing transactions. Our clients range from the nation’s largest corporations to leading investment banks…
Business Litigation & Dispute Resolution
Business Litigation & Dispute Resolution
DarrowEverett’s Business Litigation & Dispute Resolution team consists of highly skilled, experienced attorneys with an impressive track record of success in complex, high stakes litigation before federal and state…
Private Wealth Services
Private Wealth Services
In the complex and ever-changing landscape of wealth management, clients require sophisticated counsel for individuals, businesses, organizations, foundations, and families to ensure the preservation of wealth, orderly…
Tax
Tax
DarrowEverett’s tax attorneys work with a broad range of clients, including energy companies, real estate investors and developers, private equity firms, financial institutions, large privately held manufacturers, construction…
Private Equity, Capital Markets, and Securities
Private Equity, Capital Markets, and Securities
DarrowEverett’s Private Equity, Capital Markets, and Securities team is uniquely positioned to advise domestic and international public and private companies of all sizes. We regularly advise on structuring capital or debt raises…
Labor & Employment Law
Labor & Employment Law
DarrowEverett’s Labor & Employment Law Practice provides legal guidance that takes the guesswork out of complex employment matters so that our clients can focus on running their business…
Intellectual Property & Technology
Intellectual Property & Technology
DarrowEverett’s Intellectual Property & Technology Practice diligently serves our clients by handling an extensive array of intellectual property & technology services. We have a deep understanding of both specialized…
Corporate & Business Transactions
Corporate & Business Transactions
DarrowEverett’s Corporate and Business Transactions attorneys work together to provide our clients with extensive guidance in entity formation, maintenance and structuring activities; corporate governance…
Healthcare and Life Sciences
Healthcare and Life Sciences
The DarrowEverett Health Care & Life Sciences Practice advises clients across the heavily regulated and consistently evolving health care and life sciences industry. Service providers including hospitals; facilities; manufacturers;…
Regulatory and Compliance
Regulatory and Compliance
Legislation, regulations, enforcement actions, and industry guidelines, at both the federal and state level, can significantly impact both a company’s business operations in the present and its strategic planning for the future…
Government Investigations
Government Investigations
DarrowEverett’s Government Investigations Practice represents individuals, corporations, senior executives, officers, board members, and other licensed, as well as unlicensed professionals subject to government…
Environmental
Environmental
DarrowEverett’s Environmental Practice Group provides legal guidance in this heavily regulated and continually evolving industry. We assist companies, developers, and investors across numerous industries navigate…
Restructuring
Restructuring
DarrowEverett’s Restructuring Practice Group has the expertise to assist our clients in any distressed business situation. Our practitioners work aggressively to represent our clients’ interests, whether those entail maximizing…
Energy & Natural Resources
Energy & Natural Resources
DarrowEverett’s Energy and Natural Resources Practice Group provides legal guidance in these rapidly changing industries. We assist companies, developers, and investors across numerous industries manage energy-related…
Family Law
Family Law
DarrowEverett’s family law practitioners cover a broad range of needs and complex matters, from navigating divorces, custody battles and child support issues. We know that most clients simply want to feel heard and get through a difficult time in one piece.…
Data Privacy and Cybersecurity
Data Privacy and Cybersecurity
In our increasingly digital world, electronic data can flow freely between people and businesses, and laws aimed at consumer data may critically impact your legal compliance.…